Type 2 Diabetes MellitusPhase 2NCT01918865
Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes
A Phase 2 study testing ISIS-PTP1BRx and daily OAD (metformin and/or sulfonylurea) in people with Type 2 Diabetes Mellitus and Obese, run by Ionis Pharmaceuticals, Inc. at 21 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obese
- What is being tested?
- ISIS-PTP1BRx and daily OAD (metformin and/or sulfonylurea)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 21 sitesin 3 countries
- Study dates
- Aug 2013to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) >/= 27 kg/m2
- HbA1c between 7.5% and 10.5% (inclusive)
- C-Peptide (fasting) greater than or equal to 500 pmol/L
- On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for >/= 3 months prior to screening, and remain on stable dose throughout the study
- Agree to conduct home-based (fasted) blood glucose testing as directed
Who cannot join
- Clinically significant abnormalities in medical history or physical exam
- Serum creatinine > ULN at Screening
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT or AST > 1.5x ULN at Screening
- History of renal transplantation or renal dialysis
- GFR < 60 mL/min at Screening
- History of diabetic ketoacidosis
Show all 11Show fewer
- History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
- Allergy to sulfur containing drugs
- Treatment with other drugs or medications not allowed per study specific Disallowed Concomitant Medicines
- Any other significant illness or condition that may interfere with the patient participating or completing the study
- Inability or unwillingness to comply with protocol or study procedures
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
South Africa12 sites
Isis Investigational Site
Benoni, Benoni, 1500
Isis Investigational Site
Bloemfontein, Bloemfontein, 9301
Isis Investigational Site
Cape Town, Western Cape, 7570
Isis Investigational Site
Cape Town, Western Cape
Isis Investigational Site
Centurion, Gauteng, 0154
Isis Investigational Site
Durban, KwaZulu-Natal
Isis Investigational Site
Limpopo, Thabazimbi, 0380
Isis Investigational Site
Mamelodi, Gauteng, 0122
Isis Investigational Site
Middelburg, Mpumalanga
Isis Investigational Site
Port Elizabeth, Korsten
Isis Investigational Site
Pretoria, Gauteng, 0001
Isis Investigational Site
Pretoria, Pretoria, 0184
Canada7 sites
Isis Investigational Site
Edmonton, Alberta, T6G 2E1
Isis Investigational Site
Etobicoke, Ontario, M9R 4E1
Isis Investigational Site
Kelowna, British Columbia, V1Y 3G8
Isis Investigational Site
Saskatoon, Saskatchewan, S7K 3H3
Isis Investigational Site
Toronto, Ontario, M4G 3E8
Isis Investigative Site
Toronto, Ontario, M9V 4B4
Isis Investigational Site
Vancouver, British Columbia, V6J 1S3
Argentina2 sites
Isis Investigative Site
Mar del Plata, Buenos Aires, B7600FZN
Isis Investigative Site
Rosario, Santa Fe Province, S2000CVD
About this study
Official title: A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 404173 Administered Once Weekly to Obese Patients With Type 2 Diabetes Mellitus Being Treated With Metformin or Metformin Plus Sulfonylurea
The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s.
- Conditions
- Type 2 Diabetes Mellitus, Obese
- Being tested
- ISIS-PTP1BRx, Placebo, daily OAD (metformin and/or sulfonylurea)
- Keywords
- Type 2 Diabetes Mellitus, T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS-PTP1BRxDrug
PlaceboDrug
daily OAD (metformin and/or sulfonylurea)Drug
| Study group | Role | What they receive |
|---|---|---|
| ISIS-PTP1BRx | Experimental | Weekly Dosing for 26 Weeks Receives: Drug: ISIS-PTP1BRx; Drug: daily OAD (metformin and/or sulfonylurea) |
| Placebo | Placebo comparator | Weekly Dosing for 26 Weeks Receives: Drug: Placebo; Drug: daily OAD (metformin and/or sulfonylurea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety
Measured: 38 weeks
Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy
Measured: 27 weeks
Secondary outcomes (1)
Change in FPG, weekly average SMPG, seven-point glucose profile, lipid profile, body weight, & BMI at Week 27 compared to Baseline as a measure of efficacy
Measured: 27 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918865
- Sponsor's protocol ID
- ISIS 404173-CS2
- Status last verified
- Sep 2014
- First submitted
- 5 Aug 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Digenio A, Pham NC, Watts LM, Morgan ES, Jung SW, Baker BF, Geary RS, Bhanot S. Antisense Inhibition of Protein Tyrosine Phosphatase 1B With IONIS-PTP-1BRx Improves Insulin Sensitivity and Reduces Weight in Overweight Patients With Type 2 Diabetes. Diabetes Care. 2018 Apr;41(4):807-814. doi: 10.2337/dc17-2132. Epub 2018 Feb 9.
PubMed 29439147
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 404173 Administered Once Weekly to Obese Patients With Type 2 Diabetes Mellitus Being Treated With Metformin or Metformin Plus Sulfonylurea
- ClinicalTrials.gov ID
- NCT01918865
- Acronym / sponsor ID
- ISIS 404173-CS2
- Conditions
- Type 2 Diabetes Mellitus, Obese
- Keywords
- Type 2 Diabetes Mellitus, T2DM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISIS-PTP1BRx | Experimental | Drug: ISIS-PTP1BRx, Drug: daily OAD (metformin and/or sulfonylurea)Weekly Dosing for 26 Weeks |
| Placebo | Placebo comparator | Drug: Placebo, Drug: daily OAD (metformin and/or sulfonylurea)Weekly Dosing for 26 Weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) >/= 27 kg/m2
- HbA1c between 7.5% and 10.5% (inclusive)
- C-Peptide (fasting) greater than or equal to 500 pmol/L
- On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for >/= 3 months prior to screening, and remain on stable dose throughout the study
- Agree to conduct home-based (fasted) blood glucose testing as directed
Key exclusion criteria (11 listed)
- Clinically significant abnormalities in medical history or physical exam
- Serum creatinine > ULN at Screening
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT or AST > 1.5x ULN at Screening
- History of renal transplantation or renal dialysis
- GFR < 60 mL/min at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISIS-PTP1BRx | Drug | ISIS-PTP1BRx |
| Placebo | Drug | Placebo |
| daily OAD (metformin and/or sulfonylurea) | Drug | ISIS-PTP1BRx, Placebo |
Primary outcome
Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety
Time frame: 38 weeks
Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy
Time frame: 27 weeks
1 secondary outcome
Change in FPG, weekly average SMPG, seven-point glucose profile, lipid profile, body weight, & BMI at Week 27 compared to Baseline as a measure of efficacy
Time frame: 27 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Derived from this study: PubMed 29439147Digenio A, Pham NC, Watts LM, Morgan ES, Jung SW, Baker BF, Geary RS, Bhanot S. Antisense Inhibition of Protein Tyrosine Phosphatase 1B With IONIS-PTP-1BRx Improves Insulin Sensitivity and Reduces Weight in Overweight Patients With Type 2 Diabetes. Diabetes Care. 2018 Apr;41(4):807-814. doi: 10.2337/dc17-2132. Epub 2018 Feb 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISIS-PTP1BRx and daily OAD (metformin and/or sulfonylurea) in people with Type 2 Diabetes Mellitus and Obese, run by Ionis Pharmaceuticals, Inc. at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Africa, Canada, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety (time frame: 38 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.